GINGIMED  - stannous fluoride liquid 
Massco Dental A Division of Dunacin Pharmaceuticals

----------

ACTIVE INGREDIENT

STANNOUS FLUORIDE

INACTIVE INGREDIENTS

GLYCERIN, FLAVOR

USE

APPROVED USES:  RELIEF OF DENTINAL HYPERSENSITIVITY.  CONTROL OF PERIO INFECTION.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS FOR USE

ADULTS AND CHILDREN 6 YEARS AND OLDER: RINSE EACH DAY AFTER USUAL BRUSHING AND FLOSSING OR MORE OFTEN IF YOUR DENTIST RECOMMENDS ADDITIONAL THERAPY BASED ON THE DIAGNOSIS.  PUSH DOWN ON PUMP TWICE OR POUR THE CONCENTRATED RINSE TO THE 1/8 FL. OX. MARK ON THE MIXING VIAL.  ADD WATER TO THE 1 OZ. LINE.  CLOSE TIGHTLY WITH SNAP-ON CAP AND SHAKE WELL.  THIS PREPARES A 0.1% STANNOUS FLUORIDE RINSE.  RINSE WITH ONE HALF OF THE SOLUTION FOR ONE MINUTE, EXPECTORATE (SPIT) AND REPEAT THE PROCEDURE WITH THE REMAINING HALF OF THE MIXTURE.  DO NOT SWALLOW AND DO NOT RINSE MOUTH.  RINSE MIXING VIAL WITH WATER AFTER EACH USE.

CHILDREN 6-12 YEARS: INSTRUCT AND SUPERVISE IN GOOD RINSING HABITS. (HELP TO MINIMIZE SWALLOWING)

CHILDREN UNDER 6: CONSULT A DENTIST.

FOR HOME IRRIGATION: PREPARE 1 OZ. OF GINGIMED RINSE AS DESCRIBED ABOVE.  POUR INTO IRRIGATOR RESIVOIR AND ADD 4 OZ. OF WATER.  MIX THOROUGHLY.  USE IRRIGATOR AS DESCRIBED

OTHER INFORMATION

THIS PRODUCT MAY CAUSE MINIMAL SURFACE DISCOLORATION ON THE TEETH, MAY BE PREVENTED BY ADEQUATE BRUSHING.

WARNINGS

IF MORE THAN AMOUNT DIRECTED FOR RINSING IS ACCIDENTALLY SWALLOWED, SEEK MEDICAL HELP FROM A POISON CONTROL CENTER.  DO NOT USE BEFORE MIXING WITH WATER.  USE AS DIRECTED BY A DENTAL PROFESSIONAL.  THIS IS A FLUORIDE TREATMENT RINSE, NOT A MOUTHWASH.

PACKAGE LABEL

ALCOHOL FREE PERIO TREATMENT.  GINGIMED  0.63% STANNOUS FLUORIDE  READ DIRECTIONS THOROUGHLY.  MIX WITH WATER BEFORE USE.

MANUFACTURED BY MASSCO DENTAL.


CINNAMON LABEL


MINT LABEL

CARRIBEAN ICE LABEL


GINGIMED 
stannous fluoride   liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-210
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.71034 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorSPEARMINT (MINT) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-210-04120 g In 1 BOTTLE, WITH APPLICATORNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

GINGIMED 
stannous fluoride   liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-211
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.71034 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPE (CARIBBEAN ICE) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-211-06120 g In 1 BOTTLE, WITH APPLICATORNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

GINGIMED 
stannous fluoride   liquid
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63783-212
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
STANNOUS FLUORIDE (FLUORIDE ION) STANNOUS FLUORIDE.71034 g  in 120 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
XYLITOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorCINNAMON (CINNAMON) Imprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163783-212-06120 g In 1 BOTTLE, WITH APPLICATORNone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/1989

Labeler - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)
Registrant - Massco Dental A Division of Dunacin Pharmaceuticals (008081858)
Establishment
NameAddressID/FEIOperations
Massco Dental A Division of Dunacin Pharmaceuticals008081858manufacture
Revised: 04/2011Massco Dental A Division of Dunacin Pharmaceuticals